Royal decree threatens Belgian botanicals

The Belgian government has drafted a law that threatens to
reclassify as medicines up to 150 botanicals commonly used as food
supplements.

The draft Royal decree issued by the Belgian Medicines Agency
(AFMPS) seeks to introduce the 2004 European Union Traditional
Herbal Medicinal Products Directive (THMPD) into the Belgian
legislature but its "medicinal tone"​ has raised fears
among Belgian industry that an anti-supplements program may
result.
Member states have been transposing the THMPD into their
legislatures on varying timeframes since its 2004 inception.
Nathalie Guillaume, secretary general at the Belgian Federation for
Food Supplements, Dietary and Organic Products (NAREDI), said there
were several threatening aspects of the legislation.
The decree gives companies only six months to apply to notify
products with AFMPS from the date of publication which could be as
early as June this year. The THMPD gives companies until the
end of 2011 to gain registrations where required.
Guillaume questioned the legality of the draft decree's six-month
timeframe and was therefore advising NAREDI members to ignore the
call to register products, a process that costs up to €2500 per
product.
"These products, such as valerian and about 250 other
botanicals, have been classified under Belgian food law since
1997,"​ Guillaume told NutraIngredients.com. "Now it seems
there is a desire to reclassify them as medicines. We do not
understand where this is coming from." ​
NAREDI said AFMPS intended to delete "ambivalent plants" - those
used in both foods and supplements such as valerian - from the
positive list of botanicals authorised for food supplements use
under the 1997 Royal decree.
Garlic ​
This was because for many of them, like garlic, European Medicines
Evaluation Agency (EMEA) monographs existed and were therefore
being considered by AFMPS as 'medicinal by function' as specified
in the THMPD.
However, in September 2007 the German government was ordered by the
European Court of Justice (ECJ) to classify garlic supplements
under food law after its medicinal treatment of them was challenged
by the European Commission.
The ECJ found that Germany's position was an unfair barrier to
trade within the bloc and also that "the intended use" of the
product was not medicinal and therefore garlic supplements should
not be classified as such.
"Many of the botanicals AFMPS considers as being 'ambivalent'
are consumed in exactly the way and available for purchase in the
same was as garlic supplements are in Germany, so we think there is
a case for their classification remaining under food law if the
government pursues the line it is taking with this,"​ she
said.
However she declined to highlight examples and said NAREDI was
lobbying to have the decree amended.